Kornimate/medical-research-clean huggingface dataset:
behavioral economic approaches to increase physical activity among patients with elevated risk for cardiovascular disease

Conditions: Atherosclerotic Cardiovascular Disease

Summary: the objective of this study is to use a randomized, controlled trial to test the effectiveness of using gamification, financial incentives, or both to increase physical activity among patients with elevated risk for atherosclerotic cardiovascular disease (ascvd). ascvd is the leading cause of morbidity and mortality in the united states. regular physical activity has been shown to reduce the risk of ascvd, but less than 50% of us adults achieve enough physical activity to obtain these benefits.

atherosclerotic cardiovascular disease (ascvd) is the leading cause of morbidity and mortality in the united states (us). regular physical activity has been demonstrated to reduce the risk of ascvd and is associated with a number of other health benefits. yet, less than 50% of adults in the us achieve enough physical activity to actually obtain these benefits. insights from behavioral economics have been shown to both better reflect the 'predictable irrationality' of humans and to be effective in designing interventions that achieve sustained improvements in health behavior. our prior work has demonstrated that interventions using financial incentives and gamification can leverage principles from behavioral economics to increase physical activity during 3-month interventions and sustain effects in 3-month follow-up periods. these findings warrant further investigation of longer-term effects. in this study, we conduct a four-arm randomized, controlled trial to evaluate the effectiveness of using behavioral economic approaches including gamification, financial incentives, or both to increase physical activity among patients with elevated risk for atherosclerotic cardiovascular disease during a 12-month intervention with a 6-month follow-up.

Eligibility criteria:
inclusion criteria: * age 18 years or older * have a 10-year ascvd risk score of 7.5% or greater (including those with existing ascvd) * are able to provide informed consent exclusion criteria: * are already participating in another physical activity study * an 18-month physical activity program is infeasible (e.g. metastatic cancer; unable to ambulate or provide informed consent) or unsafe (currently pregnant or told by a physician not to exercise) * they do not have a device (e.g. smartphone, tablet, or computer) to transmit data from the wearable activity tracker * baseline step count is 7,500 or greater * they do not have a primary care physician in the university of pennsylvania health system.
study evaluating the pharmacokinetics of keppra extended release (xr) in children and adults with epilepsy

Conditions: Epilepsy

Summary: to study how the body absorbs, distributes, metabolises and eliminates keppra xr in both children (12 to 16 years old) and adults (18 to 55 years old) with epilepsy.


Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of epilepsy on up to three concomitant anti-epileptic drugs * subjects on levetiracetam immediate release (ir) can be enrolled if on a stable dose for 7 days exclusion criteria: * subjects with a history of status epilepticus within 3 months of visit 1 * subject has difficult venous accessibility

Keywords: levetiracetam epilepsy children adults
gene correction in autologous cd34+ hematopoietic stem cells (hbs to hba) to treat severe sickle cell disease

Conditions: Sickle Cell Disease

Summary: this study is a first-in-human, single-arm, open-label phase i/ii study of nula-cel in approximately 15 participants, diagnosed with severe sickle cell disease. the primary objective is to evaluate safety of the treatment in this patient population, as well as preliminary efficacy and pharmacodynamic data.

participants diagnosed with severe scd will receive nula-cel via iv infusion following myeloablative conditioning in an autologous hsct setting.

Eligibility criteria:
inclusion criteria: * ≥12 to ≤ 40 years * severe disease, as defined by having experienced at least one of the following scd-related events despite appropriate supportive care measures: * recurrent severe voc (≥ 4 episodes in the preceding 2 years) * acs (≥ 2 episodes in the prior 2 years with at least one episode in the past year) * lansky/karnofsky performance status of ≥ 80 exclusion criteria: * available 10/10 hla-matched sibling donor * prior hsct or gene therapy * prior or current malignancy or myeloproliferative or a significant coagulation or immunodeficiency disorder * clinically significant and active bacterial, viral, fungal or parasitic infection * pregnancy or breastfeeding in a postpartum female * presence of a chromosomal abnormality/mutation that may put the participant at an increased risk for mds or aml per investigator's judgment

Keywords: sickle cell disease sickle cell anemia gene correction gene therapy crispr
tocilizumab and cytokine release syndrome (crs) in covid-19 pneumonia

Conditions: Cytokine Release Syndrome; Covid-19 Pneumonia

Summary: tocilizumab (tcz), interleukin-6 (il-6), newly appeared as treatment of cytokine release syndrome (crs) in patients with severe covid-19 associated pneumonia. in the present study, we aimed to discuss the treatment response of tcz therapy in covid-19 infected patients.

this observational study was designed just to visualize the efficacy and safety of tocilizumab, an antibody anti-il-6 receptor in patients with moderate to severe covid-19 with increased inflammatory markers.patients will be followed until day 29 after randomization.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old; clinical diagnosis of sars-cov-2 virus by pcr, or by other approved diagnostic methodology, or, with presumptive diagnosis of covid-19 (other respiratory causes ruled out and covid-19 test pending); hospitalized with covid-19-induced pneumonia; elevated crp, d-dimers or ferritin levels; bodyweight ≥ 40kg. exclusion criteria: * eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab; use of tocilizumab within 3 weeks prior; suspected or known active bacterial, fungal, or parasitic infection (besides covid-19); patients with significant neutropenia (anc \<1000/mm3); treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to tocilizumab dose.

Keywords: cytokine release syndrome covid-19 pneumonia tocilizumab
rehabtouch home therapy for stroke patients

Conditions: Cerebral Stroke

Summary: we will investigate the efficacy of a newly developed exercise device (rehabtouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. rehabtouch uses embedded sensors that can track and record the patient's direction and degree of movement as they perform exercises described on a computer.


Eligibility criteria:
inclusion criteria: * age: 18 to 85 years old * upper extremity weakness measured by a clinical scale * absence of moderate to severe pain on affected upper extremity * able to understand the instructions to operate rehabtouch exclusion criteria: * concurrent severe medical problems, visual deficits, severe neglect or apraxia * enrollment to other therapy studies
examining the effect of acupuncture on sleep difficulties related to post traumatic stress disorder

Conditions: Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders

Summary: the purpose of this study was to examine if group ear acupuncture improves post-traumatic stress disorder sleep difficulties among veterans who participated in operations enduring freedom and iraqi freedom. this study also examined the degree of veteran acceptance for a group ear acupuncture procedure.

background: approximately 70-91% of veterans with post-traumatic stress disorder (ptsd) report insomnia. presently, conventional treatments for ptsd-related insomnia include medications, psychotherapy, and cognitive behavioral therapy. while some of these conventional treatments do improve ptsd-related insomnia, many of these treatments have limitations (e.g., medication effects, lengthy time commitments, psycho-social stigma). because of these limitations, many veterans are increasingly turning to complementary and alternative therapies to relieve their symptoms. there is a growing body of research that shows that acupuncture may improve many health symptoms including depression, ptsd, addiction, headaches, musculoskeletal pain, and insomnia. however, to date, no study has specifically explored how acupuncture may affect ptsd-related insomnia. because so many veterans with ptsd experience ptsd-related insomnia, and because the current conflicts in southwest asia are producing a new generation of combat veterans, it is critical that the va explore innovative treatments for ptsd-related health concerns.

Eligibility criteria:
inclusion criteria: 1. combat veteran of operation iraqi freedom or operation enduring freedom conflicts; 2. diagnosed with post traumatic stress disorder (ptsd) per diagnostic statistical manual (dsm) iv criteria; 3. have insomnia as indicated by a score equal to or greater than 8 on the insomnia severity index (isi); 4. diagnosis of insomnia made after ptsd diagnosis; and 5. if on psychotropic medications, must be on stable psychotropic medication regimen for one month prior to enrollment in study. exclusion criteria: 1. does not speak english; 2. not competent to sign informed consent; 3. history of moderate or severe traumatic brain injury 4. start use of continuous positive airway pressure (cpap) or bilevel positive airway pressure (bipap) during the study. 5. experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis; 6. history of substance abuse dependence (as defined per dsm iv criteria) during the one year preceding enrollment in the study or history of illicit substance use for 3 months prior to study enrollment or positive audit c score at study enrollment (defined as score of 5 and above). 7. received acupuncture during past 3 months. 8. on coumadin, heparin, or lovenox 9. pregnancy

Keywords: veterans operation iraqi freedom operation enduring freedom combat disorders acupuncture complementary therapies
dasatinib added to gemcitabine for subjects with locally-advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.


Eligibility criteria:
inclusion criteria: * histologic or cytologic documentation of unresectable adenocarcinoma of the pancreas. * recovery from toxicity of previous procedures to establish the diagnosis. ecog ps 0 or 1. * adequate organ function. exclusion criteria: * evidence of metastatic disease. * previous radiotherapy or chemoradiotherapy. * history of or current pleural effusion. * history of significant cardiovascular disease. * clinically significant bleeding disorder or coagulopathy. * concomitant medication with strong cyp 3a4 inhibitor.

Keywords: pancreatic cancer dasatinib chemotherapy locally advanced
quality of life and pain pressure threshold in response to scar release techniques for chronic transverse abdominal scar

Conditions: Cesarean Section Complications

Summary: postoperative scarring is one of the most common concerns among surgical patients. the incidence of abnormal scarring, i.e. keloid or hypertrophic scar formation after caesarean section (cs) is reported to be 41% .that can lead to functional limitations, pruritus, pain and cosmetic issues. so, the purpose of this study is to investigate quality of life and pain pressure threshold in response to myofascial induction and direct scar release techniques for lower transverse abdominal scar

this study will be conducted on forty women with chronic lower transvers abdominal scar , they will be referred from department of obstetrics and gynecology ,kasr eleiny teaching hospital and outpatient clinic of faculty of physical therapy, cairo university, egypt. all women will be randomly divided into two equal groups: * group a(study group):it will include 20 women who will be treated by myofascial induction and direct scar release techniques in addition to therapeutic ultrasound, 2 sessions per week for two weeks. * group b(control group):it will include 20 women who will be treated by therapeutic ultrasound, 2 sessions per week for two weeks.

Eligibility criteria:
inclusion criteria: * women with a well healed, old , transverse cesarean section scar (more than 6 months resulted in chronic scar pain). * pain can be intermittent or constant at rest or with activity, and it is reported to be at least at a level of about 3/ 10 on visual analogue scale at recording sites will be marked on the c-section scar at 2.5 cm intervals (wasserman et al., 2018). * women identified that the pain is either located in the cesarean section scar or caused by palpation of scar and it presents since the time of surgery not prior to the cesarean section. * their ages will range from 25-35 years old. * their bmi will be 18.5-29.9 kg/ m². exclusion criteria: * acute and subacute cesarean section. * delayed wound healing. * history of abdominal or pelvic cancer. * active pelvic or abdominal infection. * skin irritation/inflammation at the site of scar. * currently pregnant women.
bat cow's milk for the replacement of the food challenge test

Conditions: Cow Milk Allergy

Summary: the prevalence of children suspected of a cow's milk allergy is 17% in the netherlands. cow's milk diagnosis is based on a food challenge test however, this food challenge test is expensive, time consuming, risky, with waiting lists of several months. this waiting time results in unnecessarily long-term use of expensive hypoallergenic milk formula therefore, there is a great need to introduce a better and faster diagnostic test for cow's milk allergy diagnosis in standard care. the in vitro basophil activation test (bat) is cheap, quick (result \< 1 day, no waiting list), safe for the child and is a reliable alternative for the food challenge test to diagnose an ige-mediated allergy. a diagnostic work-up with the bat is expected to achieve a relevant reduction in the number of expensive and risky food challenges and the prescription of hypoallergenic formula. the reduction in diagnostic delay will increase quality of life. objective: determination of the (cost)effectiveness of the replacement of the expensive, risky and time-consuming food challenge test by the basophil activation test (bat) for the diagnosis of an ige-mediated cow's milk allergy in children.


Eligibility criteria:
inclusion criteria: 1. age 0-12 years 2. suspected of cow's milk allergy with one or more of the following complaints after intake of cow's milk: * angioedema * urticaria * sneezing and rhinitis \<2 hours after feeding * sensation of swelling in the throat and/or difficulty swallowing \<2 hours after feeding * voice change/hoarseness \<2 hours after feeding * cough \<2 hours after feeding * wheezing and/or shortness of breath \<2 hours after feeding * loss of consciousness \<2 hours after feeding * vomiting or abdominal pain or diarrhoea \<2 hours after feeding in children \<4 years only in combination with ige-mediated complaints in other tracts 3. placed on a waiting list for a hospital food challenge test 4. blood draw for cow's milk sige and bat \< 3 months before the food challenge test. this blood draw will be simultaneously scheduled with a blood draw for regular diagnostics. 5. signed informed consent parents/guardians exclusion criteria: 1. age \> 12 years 2. suspicion of food protein-induced enterocolitis syndrome (fpies) 3. eosinophilic esophagitis due to a cow's milk allergy 4. suspected cow's milk allergy \<4 years with crying and/or agitation and/or eczema and/or abdominal pain and/or failure to thrive and/or blood loss per anum and/or diarrhoea and/or reflux and/or vomiting as the only manifestation of the allergy without ige-mediated symptoms in another organ system 5. systemic immunosuppressant use 6. other underlying chronic conditions (immunological, oncological, chromosomal abnormalities).

Keywords: basophil activation test cow's milk oral food challenge
azithromycin versus erythromycin for preterm prelabor rupture of membranes

Conditions: Preterm Premature Rupture of Membrane

Summary: aim 1. to examine the latency period according to antibiotic regimens (erythromycin iv for two days followed by orally for 5 days vs. azithromycin iv for 2 days followed by 5 days orally). aim 2. to examine the latency period according to races stratified by antibiotic regimens. aim 3: to examine if there is a difference in neonatal morbidity and mortality stratified by antibiotic regimen.

significant differences exist in the pharmacokinetics and pharmacodynamics pathways of macrolide antibiotics between different races and ethnicities. erythromycin compared to azithromycin interacts with more proteins and is likely affected by genetic variation. therefore, the investigators hypothesize that the optimal latency antibiotic regimens for pprom could potentially differ between races. due to the paucity of data regarding the use of an azithromycin regimen for latency antibiotics, the eastern virginia medical school mfm team uses an erythromycin regimen even though azithromycin requires less frequent dosing, has lower rates of side effects, and is more cost effective. the center for maternal and child health equity at eastern virginia medical school was developed to address health disparities for mothers and their children, and the investigator team is committed to working with the center to address this research gap regarding latency antibiotic use in pprom. the aim is to determine the optimal antibiotic regimen for women with pprom. the hypothesis to be tested are 1) the antibiotic regimen with azithromycin (iv for 2 days followed by 5 days orally) is associated with a longer latency period compared to the antibiotic regimen with erythromycin, and 2) the antibiotic regimen with azithromycin reduces disparity in latency period compared to the antibiotic regimen with erythromycin.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * pprom from 22 weeks 0 days to 31 weeks 6 days at sentara norfolk general hospital * membrane rupture within 36 hours of randomization, cervical dilation 3 cm or less, and 4 or fewer contractions in the 60-minutes monitoring before randomization exclusion criteria: * non-reassuring fetal heart tracing * vaginal bleeding * indications for delivery * received any antibiotic therapy within 7 days other than initiation of ampicillin treatment as part of latency antibiotics prior to transfer to sentara norfolk general hospital * allergy to penicillin, erythromycin, or azithromycin
topical timolol benefit in venous ulcers

Conditions: Venous Leg Ulcers

Summary: background: venous leg ulcers are a frequent pathology in dermatology and complex in their management. at the origin of high health costs and strong repercussions on quality of life for patients, they require long management and may be subject to possible complications. in spite of appropriate treatment, 50-60% of these ulcers are not healed at 24 weeks. purpose: topical beta adrenergic antagonists have shown efficacy in wound healing. the purpose of this study is to evaluate the efficacy and safety of treatment of chronic venous ulcers with topical timolol.

abstract: complicating severe stages of chronic venous insufficiency, venous leg ulcers are common in dermatology and responsible for important health care costs. healing remains long with many persistent cases after one year, despite compression and local dressings. several pharmacological studies have demonstrated a benefit of beta-blockers on the wound healing process: present in the skin, the beta-adrenergic receptors play a role in wound healing. their stimulation inhibits healing while blocking them promotes angiogenesis, fibroblast migration and keratinocyte migration. using the topical timolol in several patients seems to confirm these effects: all ulcers treated with timolol healed in a few weeks whereas they did not evolve under local care and compression. the purpose of this study is to demonstrate whether there is an interest in topical timolol for venous leg ulcers in combination with compression and wound dressings versus placebo. the primary endpoint is to evaluate the healing rate to w12. the effects will be evaluated with photography, evaluation of the surface of the ulcer at w12 compared to w0. the research of side effects will also be evaluated.

Eligibility criteria:
inclusion criteria: * affiliated to a social security scheme patients * informed consent * patients over 18 years * ulcer lasting for at least 24 weeks with no improvement observed after 4 weeks of well conducted treatment (compression and local care) * presence of one or more venous leg ulcers (objectified by a doppler ultrasound dated within 6 months and abpi ≥ 0.8) * ulcers with a surface of 5 to 50 cm ² and at granulation stage * study ulcer must be at least 2 cm from any other ulcer on same extremity. * if several ulcers present, the greatest is selected * granulation tissue ≥ 50% exclusion criteria: * minors under guardianship, deprived of liberty, not looking at treatment, lack of signed consent, pregnant women, demented patients * ulcer lasting for less than 24 weeks * granulation tissue \<50% * obliterative arteritis (abpi \<0.8) * infection of the ulcer (need to treat the infection before any inclusion criteria be compatible) * non-cardioselective beta-blocker treatment * bradycardiac treatment * patients under diltiazem, verapamil (calcium antagonists) * reaching underlying noble structures, tumor acutisation wound * immunosuppression * diabetes unbalanced (hba1c\> 8%) * severe malnutrition (albumin \<25g / l) * anemia \<10g/dl * contraindication to beta-blockers

Keywords: leg ulcer wound topical timolol